Job Description

Collects samples for Environmental monitoring (EM) and Utilities monitoring (UM). Responsible for all sample collection and logistics as needed.

Coordinates testing materials and supplies needed for testing

Performs Basic Microbiology laboratory testing following standard procedures for all samples, including but not limited to all in-process samples, raw materials, EM and utilities samples for Bioburden, Endotoxin, plate reading, and microbial identification

Performs sterility testing, isolator qualification and routine operations and maintenance

Sample and data entry into LIMS system

Reviews general lab testing results

Troubleshoots routine assays

General laboratory support and laboratory maintenance in a cGMP laboratory including maintaining laboratory supplies needed for operations, maintenance of analytical instruments, purchasing and receiving of laboratory supplies (media, kits, etc.)

Ensures CAPAs are being followed in the laboratory areas

Notifies client management and assists with the initiation of events (such as deviations) in the quality systems